Recruiting

Observational Study

Sponsor:

Adams Clinical

Code:

NCT06104852

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Survey

Optional Medication Washout

Study Details

Brief summary:

TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.

Conditions

Alzheimer Disease

Study ID

NCT06104852

Start date

Jun 2, 2023

Status verified date

Oct, 2023

Completion date

Jun 2, 2027

Anticipated

Primary completion date

Jun 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participant and study partner (when applicable) have signed an ICF prior to study-specific procedures being performed.
  • Participant and study partner (when applicable) are at least 18 years old.

Exclusion Criteria:

  • Participant lacks the language skills or cognitive ability to understand the screening process.
  • Participant is pregnant, breast-feeding, or planning to become pregnant.
  • History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
  • Participant represents an acute suicidal risk, as defined as a "yes" response to ideation on Columbia-Suicide Severity Rating Scale questions 4 or 5, or answer "yes" to behavior questions within 90 days of screening.
  • Moderate or severe substance use disorder within 90 days prior to screening, according to DSM-5 criteria that in the investigator's opinion could pose undue risk to the participant.
  • Any condition that in the investigator's opinion makes a participant unsuitable for the study.
  • Currently employed by Adams Clinical or a first-degree relative of an employee working on this study.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Interventions

Survey

Participants will be surveyed on demographics, medical history, and current memory and cognitive concerns. Vitals signs, urine drug screen, blood draw may be collected.

Optional Medication Washout

Participants taking memory medications which require a down-taper per the judgment of the study physicians may participate in a medication washout period during study screening.

Primary outcome measure

  • Proportion of the clinical trial seeking population for whom industry-sponsored clinical research is clinically appropriate, as defined as those who go on to screen for a study. [ Time Frame: Up to 52 weeks ]

Central Contacts and Locations

Central contacts

Sarah J Starling, PhD

6177448542sstarling@adamsclinical.com

Locations

Adams Clinical

Recruiting

Watertown, Massachusetts, United States, 02472

Contacts

Sarah J Starling, PhD

617-744-8542sstarling@adamsclinical.com

Principal Investigator:

Sarah J Starling, PhD

Berman Clinical

Recruiting

New York, New York, United States, 10029

Contacts

Mark Rapp, MD

917-423-6797mrapp@bermanclinical.com

Principal Investigator:

Mark Rapp, MD

More Information

Sponsor

Adams Clinical

Last update posted

Oct 27, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Adams Clinical on 2023-10-27.